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K093079.pdf

K093079.pdf
Preview of K093079
🔗 Source: accessdata.fda.gov
📊 Size: 88 KB
📄 Pages: 3 pages
⬇️ Downloads: 64

Summary

The FDA has determined that the TouchSoft Coagulator device is substantially equivalent to legally marketed predicate devices and may be marketed, subject to general controls provisions of the Act, including requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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Description

The FDA has determined that the TouchSoft Coagulator device is substantially equivalent to legally marketed predicate devices and may be marketed, subject to...

Technical Information

  • File Format: PDF
  • File Size: 88 KB
  • Pages: 3
  • Language: EN
  • Total Downloads: 64
  • Last Updated: 3 weeks ago

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